Meloxicam is a drug with antipyretic, analgesic and anti-inflammatory effects.
Release form and composition
Meloxicam is available in the following dosage forms:
- Tablets: flat-cylindrical with a risk (15 mg each) or without it (7.5 mg each), from light yellow to yellow color, marbling and slight impregnations are possible, with a facet (10, 20 or 30 pieces in blister packs. , 1, 2, 3, 4, 5 or 10 packs in a cardboard bundle; in polymeric containers of 10, 20, 30, 40, 50 or 100 pcs., 1 container in a cardboard bundle; in polymer banks of 10, 20 or 100 pcs., 1 can in a cardboard box; in plastic bottles of 20 or 30 pcs., 1 bottle in a cardboard box; in dark glass cans of 20 or 30 pcs., 1 can in a cardboard box);
- Solution for intramuscular injection: transparent, yellow or greenish-yellow color (in dark glass ampoules of 1.5 ml, 3, 5 or 10 ampoules in a contour cell packaging, 1 or 2 packs in a cardboard box);
- Rectal suppositories (in blisters of 6 pieces; 1 or 2 packs in a carton box).
The composition of 1 tablet includes:
- Active ingredient: meloxicam - 7.5 or 15 mg;
- Auxiliary components: sodium citrate dihydrate, calcium stearate, primogel (carboxymethyl starch sodium), aerosil (colloidal silicon dioxide), microcrystalline cellulose, lactose, polyvinylpyrrolidone (povidone).
The composition of 1 ml solution for intramuscular injection includes:
- Active ingredient: meloxicam - 10 mg;
- Auxiliary components: meglumin - 7 mg; glycofurfural - 100 mg; glycine - 6 mg; water for injection - 1 ml; Poloxamer 188 - 50 mg; sodium chloride - 3.5 mg; sodium hydroxide solution 0.1 M - to pH 8.4-8.9.
The composition of 1 rectal suppository includes the active substance: meloxicam - 7.5 or 15 mg.
Indications for use
- Ankylosing spondylitis (ankylosing spondylitis);
- Rheumatoid arthritis;
- Other degenerative and inflammatory diseases accompanied by pain.
- Age up to 15 years;
- Severe liver failure or active liver disease;
- Severe renal failure in non-dialysis patients, progressive kidney disease (including confirmed hyperkalemia);
- Breastfeeding period;
- Hypersensitivity to the components of the drug and other nonsteroidal anti-inflammatory drugs.
Additional contraindications to the use of rectal suppositories are:
- Rectal or anal bleeding (including history);
- Inflammatory diseases of the rectum;
- Peptic ulcer of the stomach or duodenum in the acute phase.
Additional contraindications to the use of meloxicam in formetablets are:
- Decompensated heart failure;
- Inflammatory bowel disease (Crohn's disease, ulcerative colitis);
- The period after coronary artery bypass surgery;
- Active gastrointestinal bleeding, erosive and ulcerative changes in the mucous membrane of the stomach or duodenum;
- Cerebrovascular bleeding or other bleeding;
- Attacks of bronchial obstruction, rhinitis, urticaria after taking acetylsalicylic acid (ASA) or other NSAIDs (complete or incomplete intolerance syndrome ASC - urticaria, rhinosinusitis, polyps of the nasal mucosa, bronchial asthma) in history.
Additional contraindications to the use of the solution for intramuscular administration are:
- Peptic ulcer of the stomach and duodenum in the acute phase and for at least 6 months after it;
- Bleeding, including from the digestive tract, brain hemorrhage;
- Allergic reactions to ASA and other NSAIDs: bronchial asthma, recurrent polyposis of the nose and paranasal sinuses, angioedema, urticaria.
Conditions / diseases for which meloxicam tablets are prescribed with caution:
- Ulcer lesion of the gastrointestinal tract in history;
- Coronary heart disease
- Dyslipidemia / hyperlipidemia;
- Creatinine clearance (CC) is less than 60 ml per minute;
- Cerebrovascular diseases;
- Peripheral artery diseases;
- Chronic heart failure;
- Elderly age;
- Helicobacterpylori infections;
- Severe somatic diseases;
- Long-term use of NSAIDs;
- Frequent use of alcohol;
- Simultaneous administration with anticoagulants, antiplatelet agents, oral glucocorticosteroids, selective serotonin reuptake inhibitors.
Dosing and Administration
Tablets are taken orally, during the meal. The frequency of admission - 1 time per day.
- Osteoarthritis: 1 tablet (7.5) mg per day, with a possible increase in dose by 2 times (if necessary);
- Rheumatoid arthritis: 1 tablet (15 mg) per day; after reaching a therapeutic effect, the dose can be reduced by 2 times;
- Ankylosing spondylitis: 1 tablet (15 mg) per day (maximum daily dose).
In hemodialysis patients with severe renal insufficiency, as well as in patients with an increased risk of side effects, the dose should not exceed 7.5 mg per day.
The solution for intramuscular injection is advisable to use only during the first days of therapy, then it is recommended to switch to taking Meloxicam in the form of tablets. The solution can not be administered intravenously.
Rectal suppositories are used 1 time per day. Daily dose - 1 suppository. The duration of therapy is 5-7 days. In the future, it is recommended to use the drug inside.
With intramuscular meloxicam may occur:
- Gastrointestinal (GI): inflammation of the oral cavity, indigestion, gastritis, nausea, diarrhea, vomiting, bleeding from the gastrointestinal tract, flatulence, ulceration of the stomach and duodenum, pharyngitis, constipation;
- Cardiovascular system: edema; rarely - increased blood pressure, heart palpitations;
- Respiratory system: acute asthma attack;
- Central nervous system: confusion, headache, disorientation, dizziness, drowsiness, tinnitus;
- Urinary system: impaired renal function;
- Vision organs: conjunctivitis, visual impairment;
- Skin: photosensitivity, urticaria, skin rash, itching;
- Organs of hematopoiesis: thrombocytopenia, leukopenia, anemia.
When using suppositories, the following disorders may develop:
- GIT: flatulence, abdominal pain, diarrhea, dyspepsia, nausea, constipation, vomiting; rarely - belching, latent or macroscopically visible gastrointestinal bleeding, esophagitis, transient changes in liver function (increased level of hepatic transaminases or bilirubin), erosive and ulcerative lesions of the gastrointestinal tract, stomatitis; in some cases - colitis, intestinal perforation;
- Central and peripheral nervous system: headache; rarely, drowsiness, tinnitus, dizziness; in some cases - nightmares, insomnia, disorientation, mood changes;
- Cardiovascular system: edema; rarely - tachycardia, increased blood pressure;
- Urinary system: rarely - changes in laboratory parameters of renal function; in some cases, acute renal failure;
- Organs of blood formation: rarely - thrombocytopenia, leukopenia, anemia;
- Dermatological reactions: rash, itching; rarely - urticaria; in some cases - Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitization, erythema multiforme, bullous reactions;
- Allergic reactions: in some cases - hypersensitivity reactions of immediate type (including anaphylactic and anaphylactoid reactions), angioedema;
- Other: possible - local irritation reactions (burning, itching in the anorectal region); in some cases - visual impairment (including fuzziness), conjunctivitis.
When using Meloxicam in the form of tablets can occur:
- The digestive system: often - dyspepsia, including nausea, vomiting, constipation, flatulence, diarrhea, abdominal pain; infrequently - esophagitis, gastroduodenal ulcer, belching, transient increase in liver transaminase activity, bleeding from the gastrointestinal tract (including latent), stomatitis, hyperbilirubinemia; rarely - gastritis, gastrointestinal perforation, hepatitis, colitis;
- Blood formation organs: often - anemia; infrequently - changes in the blood formula (including thrombocytopenia, leukopenia);
- Skin: often - skin rash, itching; infrequently - urticaria; rarely, erythema multiforme, including Stevens-Johnson syndrome, photosensitivity, bullous rashes, toxic epidermal necrolysis;
- Respiratory system: rarely - bronchospasm;
- Nervous system: often - headache, dizziness; infrequently - drowsiness, vertigo, tinnitus; rarely - emotional lability, disorientation, confusion;
- Cardiovascular system: often - peripheral edema; infrequently - flushing, increased blood pressure, palpitations;
- Urinary system: infrequently - hypercreatininemia and / or an increase in serum urea concentration; rarely, acute renal failure; hematuria, albuminuria, interstitial nephritis (connection with the intake of the drug has not been established);
- Sense organs: rarely - conjunctivitis, visual disturbances, including blurred vision;
- Allergic reactions: rarely - anaphylactic / anaphylactoid reactions, angioedema.
Patients with renal insufficiency with creatinine clearance greater than 25 ml per minute do not need to adjust the dosage regimen.
In cases of simultaneous use of Meloxicam with diuretics, a sufficient amount of fluid should be taken.
If allergic reactions occur, it is recommended to interrupt therapy and consult a doctor.
Patients during treatment should refrain from conducting potentially hazardous activities that require psychomotor speed and increased attention, since Meloxicam may cause drowsiness, dizziness, and headache.
With the simultaneous use of meloxicam with certain drugs, undesirable effects may occur:
- Antihypertensive drugs: reducing their actions;
- Lithium preparations: an increase in their toxic action and the development of lithium cumulation;
- Methotrexate: enhancing its side effects on the hematopoietic system;
- Intrauterine contraceptives: a decrease in their effectiveness;
- Kolestiramin: enhancing its excretion through the gastrointestinal tract;
- Other nonsteroidal anti-inflammatory drugs, as well as ASA: an increased risk of bleeding and erosive and ulcerative damage to the gastrointestinal tract;
- Cyclosporine and diuretics: an increased risk of developing renal failure;
- Anticoagulants, thrombolytic drugs: an increased risk of bleeding.
Terms and conditions of storage
Store in a dark place, out of reach of children.
- Tablets - 2 years at temperatures up to 25 ° C;
- Suppositories - 2 years at temperatures up to 15 ° C;
- Solution - 3 years at a temperature up to 25 ° C.